WORKHORSE SCREW, T10, NON-LOCKING 3.5mm x 75mm

GUDID 00848665037210

ADVANCED ORTHOPEDIC SOLUTIONS INC

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00848665037210
NIH Device Record Key16d48b67-95c7-4782-9391-6ce44c0411e6
Commercial Distribution StatusIn Commercial Distribution
Brand NameWORKHORSE SCREW, T10, NON-LOCKING 3.5mm x 75mm
Version Model Number8100-075
Company DUNS117858154
Company NameADVANCED ORTHOPEDIC SOLUTIONS INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone3105339966
Emailregaffairs@aosortho.com
Phone(310) 533-9966
Emailregaffairs@aosortho.com
Phone(310) 533-9966
Emailregaffairs@aosortho.com
Phone(310) 533-9966
Emailregaffairs@aosortho.com
Phone(310) 533-9966
Emailregaffairs@aosortho.com
Phone(310) 533-9966
Emailregaffairs@aosortho.com
Phone(310) 533-9966
Emailregaffairs@aosortho.com
Phone(310) 533-9966
Emailregaffairs@aosortho.com
Phone(310) 533-9966
Emailregaffairs@aosortho.com
Phone(310) 533-9966
Emailregaffairs@aosortho.com
Phone(310) 533-9966
Emailregaffairs@aosortho.com
Phone(310) 533-9966
Emailregaffairs@aosortho.com
Phone(310) 533-9966
Emailregaffairs@aosortho.com
Phone(310) 533-9966
Emailregaffairs@aosortho.com
Phone(310) 533-9966
Emailregaffairs@aosortho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100848665037210 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone
HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00848665037210]

Moist Heat or Steam Sterilization


[00848665037210]

Moist Heat or Steam Sterilization


[00848665037210]

Moist Heat or Steam Sterilization


[00848665037210]

Moist Heat or Steam Sterilization


[00848665037210]

Moist Heat or Steam Sterilization


[00848665037210]

Moist Heat or Steam Sterilization


[00848665037210]

Moist Heat or Steam Sterilization


[00848665037210]

Moist Heat or Steam Sterilization


[00848665037210]

Moist Heat or Steam Sterilization


[00848665037210]

Moist Heat or Steam Sterilization


[00848665037210]

Moist Heat or Steam Sterilization


[00848665037210]

Moist Heat or Steam Sterilization


[00848665037210]

Moist Heat or Steam Sterilization


[00848665037210]

Moist Heat or Steam Sterilization


[00848665037210]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-24
Device Publish Date2020-04-16

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00848665027624 - SUPRAPATELLAR TIBIAL ENTRY SHEATH2020-06-08
00848665028041 - T10 Screwdriver, Short2020-06-08
00848665028096 - 3.5mm Calibrated Drill2020-06-08
00848665028119 - AOS 2.6mm Solid Reamer2020-06-08
00848665028782 - T10 Screwdriver, Solid2020-06-08

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